Pemetrexed for the Treatment of Chordoma
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03955042 |
Recruitment Status :
Completed
First Posted : May 17, 2019
Last Update Posted : March 7, 2023
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The purpose of this study is to test the safety and tolerability of pemetrexed administered to people with chordoma. Other purposes of this study are to:
- find out side effects (good and bad) of pemetrexed;
- learn more about how pemetrexed might affect the growth of cancer cells;
- evaluate tumor characteristics by collecting tumor tissue samples if available;
- look at biomarkers (biochemical features that can be used to measure the progress of disease or the effects of a drug) in blood and cerebrospinal fluid if available.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chordoma | Drug: Pemetrexed | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pilot Study of Pemetrexed for the Treatment of Chordoma |
Actual Study Start Date : | September 6, 2019 |
Actual Primary Completion Date : | July 27, 2022 |
Actual Study Completion Date : | January 18, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Pemetrexed
Pemetrexed
|
Drug: Pemetrexed
Pemetrexed 900 mg/m^2 on Day 1 of each 21-day cycle. Supportive medications of ibuprofen, folic acid, vitamin B12, and dexamethasone.
Other Name: Alimta |
- Progression free survival [ Time Frame: one year ]duration of time from start of treatment until objective tumor progression or withdrawal
- Radiographic response assessed by RECIST v1.1 [ Time Frame: one year ]rate of radiographic imaging alterations following treatment
- Toxicity assessed by CTCAE v 4.03 criteria [ Time Frame: one year ]proportion of patients experiencing adverse events
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participant has the ability to understand and the willingness to provide a signed and dated informed consent form.
- Participant has the willingness to comply with all study procedures and availability for the duration of the study.
- Participant has a diagnosis of chordoma.
- Participant is male or female, 18 years of age or older.
- Participant has a Karnofsky Performance Status of 50% or greater.
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Participant has adequate organ function:
- ANC at least 1.5 x 10^9/L or higher
- Platelets at least 100 x 10^9/L or higher
- Hemoglobin at least 8 g/dL or higher.
- Total bilirubin 1.5 x upper limit of normal (ULN) or lower.
- ALT and AST 3 x ULN or lower.
- Serum creatinine 1.5 x ULN or lower.
- Participant has the ability to interrupt non-steroidal anti-inflammatory drugs (NSAIDS) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Pemetrexed.
- Participant has the ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.
- Participant has recovered from any previous therapy-related toxicity to CTCAE Grade 1 or to their clinical baseline at study entry.
Exclusion Criteria:
- Participant is less than 28 days from any investigational agent.
- Participant has third space fluid which cannot be controlled by drainage.
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Participant has a severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study intervention, including, but not limited to:
- Uncontrolled diabetes;
- Renal disease that requires dialysis;
- Pulmonary disorder requiring supplemental oxygen to keep saturation >95% and the situation is not expected to resolve within 2 weeks;
- Severe dyspnea at rest or requiring oxygen therapy;
- Interstitial lung disease;
- History of major surgical resection involving the stomach or small bowel;
- Preexisting Crohn's disease;
- Ulcerative colitis;
- Uncontrolled vasculitis and/or disease with known vasculitis;
- Preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea;
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Participant has an active bacterial infection requiring intravenous [IV] antibiotics at time of initiating study treatment, fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C).
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Participant has a personal history or presence of any of the following cardiovascular conditions:
- Syncope of cardiovascular etiology;
- Ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation);
- Myocardial infraction within 6 months of investigational product administration;
- Unstable angina;
- Sudden cardiac arrest;
- Congestive heart failure (NYHA classification ≥ 3).
- Participant is a female of childbearing potential who is pregnant or nursing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955042
United States, California | |
John Wayne Cancer Institute | |
Santa Monica, California, United States, 90404 |
Principal Investigator: | Santosh Kesari, MD, PhD | Saint John's Cancer Institute |
Responsible Party: | Santosh Kesari, Director, Neuro-Oncology, Saint John's Cancer Institute |
ClinicalTrials.gov Identifier: | NCT03955042 |
Other Study ID Numbers: |
JWCI-18-0704 H3E-US-X091 ( Other Identifier: Eli Lilly ) |
First Posted: | May 17, 2019 Key Record Dates |
Last Update Posted: | March 7, 2023 |
Last Verified: | March 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Chordoma Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Pemetrexed |
Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |